Heart valve sizing ring for valve-sparing aortic root remodeling procedures

ABSTRACT

A heart valve sizing ring is disclosed. The sizing ring includes an outer ring and an inner ring configured and arranged to couple to the outer ring. A tubular portion extends from the inner ring and has a plurality of suture holders arranged about an upper end thereof. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. When coupled around sutures, the assembled ring may be tightened down against the heart valve to test the fit as if the sizing ring were a similarly sized prosthetic heart valve ring. Commissures of the heart valve may be suspended from the suture holders of the tubular portion. The surgeon can then remove the sizing ring and replace it with a prosthetic ring.

CROSS-REFERENCE TO RELATED APPLICATION

This patent document is a division of earlier filed U.S. patentapplication Ser. No. 14/051,787, filed on Oct. 11, 2013, which claimspriority to earlier filed U.S. Provisional Patent Application Ser. No.61/713,115, filed Oct. 12, 2012, and is a continuation-in-part of U.S.patent application Ser. No. 13/658,050, filed Oct. 23, 2012, now U.S.Pat. No. 9,889,009, which claims priority to earlier filed U.S.Provisional Patent Application Ser. No. 61/551,728, filed Oct. 26, 2011and U.S. Provisional Patent Application Ser. No. 61/555,002, filed Nov.3, 2011, and is a continuation-in-part of U.S. patent application Ser.No. 13/871,327, filed on Apr. 26, 2013, now U.S. Pat. No. 9,839,516,which claims priority to earlier filed U.S. Provisional PatentApplication Ser. No. 61/641,338, filed May 2, 2012 and U.S. ProvisionalPatent Application Ser. No. 61/639,482, filed Apr. 27, 2012, the entirecontents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Technical Field

The present patent document relates generally to heart valve sizingrings and more particularly to a heart valve sizing ring configured forvalve-sparing aortic root remodeling procedures.

2. Background of the Related Art

Referring to FIGS. 1 and 2, during valve-sparing aortic root remodelingprocedures sutures 14 are aligned at the base of the heart valve 10. Theaortic wall is resected and sculpted to preserve three anchor points forthe heart valve where the leaflets 12 meet, i.e. the commissures 16.Sutures 18 are placed above the commissures 16. The sutures 14 at thebase of the valve 10 are used to anchor the graft to the heart and tostabilize (and often “downsize”) the aortic root. The sutures 18 abovethe commissures 16 are anchored to the upper “tube” portion of the graftwhere they are positioned high enough to allow the commissures 16 to be“resuspended” helping to correct geometry of the valve 10.

However, if the correct graft size is not selected during the repair,the surgeon may not be able to properly reshape the valve 10, therebyleading prolonged and/or suboptimal surgical operations which could leadto complications and poor outcomes.

Therefore, there is a perceived need in the industry for a method anddevice to allow a surgeon to easily size and test a valve repair invalve-sparing aortic root remodeling procedures.

SUMMARY OF THE INVENTION

The present invention solves the problems of the prior art by providinga heart valve sizing ring system that includes and outer ring and aninterlocking inner ring. The inner ring further includes a tubularportion that can be used to test and simulate whether the heart valvehas been properly sized prior to installing a permanent graftprosthesis. The tubular portion may additionally include suture holdersat the top to aid the surgeon in recreating valve geometry and functionby “suspending” the commissures within the tubular portion thusassisting with evaluation/testing of proper graft/valve size selection.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 shows an aortic heart valve with sutures being installed at thebase of the valve;

FIG. 2 shows an aortic heart valve after excess and/or diseased aortictissue has been resected using a technique that preserves the valveitself. More sutures are placed circumferentially;

FIG. 3 shows the heart valve sizing system supporting the heart valvetherein for testing the size of the graft prior to placement; and

FIG. 4 shows a partial cross-section of a suture being trapped betweenthe inner ring and the outer ring.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIGS. 3 and 4, a first embodiment of the heart valvesizing ring is shown generally over a heart valve that has been resectedand sculpted at 100. The heart valve sizing ring 100 includes an outerring 102, and inner ring 104 that interlocks with the outer ring 102,and a tubular portion 106 (simulating a graft) extending from the innerring 104.

Sutures 14 at the base of the heart valve 10 are captured between theinner and outer rings 102,104, thereby temporarily anchoring the heartvalve sizing ring 100 to the heart valve 10. The inner and outer rings102, 104, may include a concave and convex surfaces 102 a, 104 b, tofacilitate retention of the sutures 14. The surfaces may optionally becoated with a rubber-type of coating to gently grip the sutures andprevent slipping. Because the inner and outer rings 102, 104 form arigid structure, the precise size of the annular diameter is providedduring evaluation.

The valve commissures 16 are suspended temporarily using the sutureholders 108, such as slots, via the commissure sutures 18. This allowsfor the valve leaflet 12 distance and apposition to be properlyevaluated by creating a “quick preview” of what valve function would belike should a graft of that size be selected. Several different graftsizes can be tested and compared in a relatively short time prior tofinal graft selection. Note that this system can be used with either a“straight” tube graft or with a “Valsalva” type of tube graft (in whichthe sides of the graft “bow” outward slightly).

The pictured slots as suture holders 108 represent one embodiment thatmay facilitate commissural suspension, though, this could beaccomplished by other mechanisms as well, such as clipping thecommissure sutures 18 to the tube wall, etc. The material of the tubularportion 106 is not restricted and can be made of a stiffer material thanthe graft prosthesis if it is only being used for sizing purposes. Theslots 108 can have an additional rubber-type of coating or some othermaterial that is advantageous in gently gripping and holding thecommissure sutures 18.

It would be appreciated by those skilled in the art that various changesand modifications can be made to the illustrated embodiments withoutdeparting from the spirit of the present invention. All suchmodifications and changes are intended to be within the scope of thepresent invention.

I claim:
 1. A method of sizing a heart valve, comprising: providing aheart valve sizing ring having an inner ring and an outer ringsnap-receivable together, the inner ring further comprising tubularportion extending therefrom, the tubular portion having an upper endwith a plurality of spaced apart suture holders thereabout; corrallingthe sutures within an outer ring; organizing the sutures within theouter ring; inserting an inner ring into the outer ring, trapping thesutures between the inner ring and the outer ring; and suspendingcommissures within the tubular portion via the plurality of sutureholders on the upper end of the tubular portion.
 2. The method of claim1, further comprising tightening the heart valve sizing ring against theheart valve.
 3. The method of claim 1, further comprising checking theheart valve for an adequate fit.
 4. The method of claim 1, furthercomprising replacing the heart valve sizing ring with a prosthetic heartvalve ring.
 5. The method of claim 1, wherein the step of corralling thesutures within the outer ring comprises gathering the sutures through agap formed in the outer ring to an interior portion of the outer ring.6. The method of claim 1, further comprising adjusting the suturessuspending the commissures.
 7. A method of sizing a heart valve,comprising: providing a heart valve sizing ring having an inner ring andan outer ring, the inner ring and outer ring configured and arranged toattach together, the inner ring further comprising tubular portionextending therefrom, the tubular portion having an upper end with aplurality of spaced-apart, suture holders; gathering the sutures withinan outer ring; inserting an inner ring into the outer ring, trapping thesutures between the inner ring and the outer ring; tightening the heartvalve sizing ring against the heart valve; and suspending commissureswithin the tubular portion via the plurality of suture holders on theupper end of the tubular portion.
 8. The method of claim 7, furthercomprising organizing the sutures within the outer ring.
 9. The methodof claim 7, further comprising checking the heart valve for propergeometry and function.
 10. The method of claim 7, further comprisingreplacing the heart valve sizing ring with a prosthetic heart valvering.
 11. The method of claim 7, wherein the step of gathering thesutures within the outer ring comprises gathering the sutures through agap formed in the outer ring to an interior portion of the outer ring.12. The method of claim 7, further comprising adjusting the suturessuspending the commissures.
 13. A method of sizing a heart valve,comprising: providing a heart valve sizing ring having an inner ring andan outer ring, the inner ring and outer ring configured and arranged toattach together, the inner ring further comprising tubular portionextending therefrom, the tubular portion having an upper end with aplurality of spaced-apart, suture holders; gathering the sutures withinan outer ring; organizing the sutures within the outer ring; insertingan inner ring into the outer ring, trapping the sutures between theinner ring and the outer ring; suspending commissures within the tubularportion via the plurality of suture holders on the upper end of thetubular portion; and adjusting the sutures and commissures to achieveproper heart valve geometry and function.
 14. The method of claim 13,further comprising tightening the heart valve sizing ring against theheart valve.
 15. The method of claim 13, further comprising replacingthe heart valve sizing ring with a prosthetic heart valve ring.
 16. Themethod of claim 13, wherein the step of gathering the sutures within theouter ring comprises gathering the sutures through a gap formed in theouter ring to an interior portion of the outer ring.